FDA lifts hold on trial of CytRx' aldoxorubicin

US regulators have removed a partial clinical hold on trials of CytRx’ late-stage cancer drug aldoxorubicin, thereby permitting immediate enrolment of new patients.

Enrolment in the trial was suspended in November following the death of a patient taking part in the trial, but the firm said that it has now modified the study parameters to avoid potential risks.

CytRx now expects to complete enrolment in the ongoing pivotal global Phase III trial testing the drug in second-line soft tissue sarcoma by the end of 2015, and to unblind the clinical data by mid-2016.

Aldoxorubicin combines the chemotherapy doxorubicin with a novel single-molecule linker that binds specifically to the bloodstream protein albumin. Albumin is concentrated in protein-hungry tumours, the acidic environment of which prompts the release of the attached doxorubicin, thus ensuring targeted delivery to diseases cells.

Subject to approval, CytRx's market launch of aldoxorubicin for second-line soft tissue sarcoma in the US is projected to commence in 2017, the firm said.